Maintaining a gluten-free diet is associated with quality of life in youths with type 1 diabetes and celiac disease.

AIM: Conflicting findings have been reported on whether in youths, the double diagnosis of type 1 diabetes (T1D) and celiac disease (CD) substantially impacts quality of life QoL, compared to subjects with T1D only. METHODS: In this study, 86 youths with double diagnosis and their parents were compared to 167 subjects with T1D only. QoL was assessed through the KINDL questionnaire. Anti-tissue transglutaminase antibodies and dietary interviews evaluated the degree of maintaining a gluten-free diet (GFD). RESULTS: We found that having CD in addition to T1D has little effect on overall QoL. However, analysis of the degree of maintaining GFD revealed significantly lower total QoL scores in groups with T1D + CD not strictly maintaining GFD compared to T1D only (p = 0.0014). The multivariable linear regression model confirmed the importance of maintaining GFD on QoL in subjects (p = 0.0066) and parents (p = 0.023). CONCLUSION: The coexistence of T1D and CD and the adoption of a GFD resulted in poor QoL levels, as in youth as in their parents, when difficulties implementing the GFD are present. Psychological support should consider the importance of maintaining GFD not only to prevent potential complications in the future but also to improve actual QoL in different subdomains.

Satisfaction with continuous glucose monitoring is associated with quality of life in young people with type 1 diabetes regardless of metabolic control and treatment type.

AIMS: While continuous glucose monitoring (CGM) and associated technologies have positive effects on metabolic control in young people with type 1 diabetes (T1D), less is known about their impact on quality of life (QoL). Here, we quantified CGM satisfaction and QoL in young people with T1D and their parents/caregivers to establish (i) the relationship between QoL and CGM satisfaction and (ii) the impact of the treatment regimen on QoL. METHODS: This was a cross-sectional study of children and adolescents with T1D on different treatment regimens (multiple daily injections, sensor-augmented pumps and automated insulin delivery). QoL was assessed with the KINDL instrument, and CGM satisfaction with the CGM-SAT questionnaire was evaluated in both youths with T1D and their parents. RESULTS: Two hundred and ten consecutively enrolled youths with T1D completed the KINDL and CGM-SAT questionnaires. The mean total KINDL score was greater than neutral in both subjects with T1D (3.99 ± 0.47) and parents (4.06 ± 0.40), and lower overall CGM-SAT scores (i.e., higher satisfaction) were significantly associated with higher QoL in all six KINDL subscales (p < 0.05). There were no differences in KINDL scores according to delivery technology or when participants were grouped according to optimal and sub-optimal glucose control. CONCLUSIONS: Higher satisfaction with recent CGMs was associated with better QoL in all dimensions. QoL was independent of both the insulin delivery technology and glycaemic control. CGM must be further disseminated. Attention on perceived satisfaction with CGM should be incorporated with the clinical practice to improve the well-being of children and adolescents with T1D and their families.

Efficacy of balneotherapy on pain, function, and sleep quality in patients with chronic low-back pain: a prospective observational study.

The aim of this prospective observational study was to evaluate the efficacy of a cycle of sulfate-arsenical-ferruginous mud bath therapy on pain, function, and sleep quality in patients with chronic low-back pain (CLBP). One hundred twenty-three patients treated at Levico Spa Center (Italy) with 12 daily local mud packs and generalized thermal baths were included in this experience. General medical assessments were performed before starting the therapy, at the end of the treatment, and 3 months later. Pain intensity and stiffness were measured by a 0 to 10 cm visual analogue scale (VAS); the range of mobility of the lumbar spine was evaluated using the Schober test and functional disability by the Roland-Morris Disability Questionnaire (RMDI). The Pittsburgh Sleep Quality Index (PSQI) was used to assess the sleep quality. The VAS score for pain and stiffness showed a significant reduction (p < 0.0001) at the end of the treatment persisting for 3 months of follow-up. Similarly, a significant improvement was found for the Schober test and RMDQ. Finally, we showed a significant decrease of PSQI score at the end of the cycle of mud bath and at 3 months of follow-up. The Spearman analysis showed a significant positive correlation between the score of PSQI and VAS pain, VAS stiffness, and RMDQ. In conclusion, this preliminary study confirms the beneficial and long-term efficacy of balneotherapy on pain and function and, for the first one, shows the positive effect on quality of sleep in patients with CLBP treated with a cycle of mud bath therapy.

Maintaining the gluten-free diet: The key to improve glycemic metrics in youths with type 1 diabetes and celiac disease.

AIMS: Gluten-free diets (GFD) were considered as high glycemic index and/or high content of saturated fats; this could affect keeping good metabolic control in individuals with both type 1 diabetes (T1D) and celiac disease (CD). Our objective was to analyze time in range and other continuous glucose monitoring (CGM) metrics with real-time CGM systems, in youths with T1D and CD, compared to those with T1D only. METHODS: An observational case-control study, comparing youths aged 8-18 years with T1D and CD, with people with T1D only was performed. The degree of maintaining GFD was assessed through anti-tissue transglutaminase antibodies and dietary interview, and maintaining Mediterranean diet through the KIDMED questionnaire. RESULTS: 86 youths with T1D and CD, 167 controls with T1D only, were included in the study and the two groups reported similar real-time CGM metrics. Among the first group, 29 % were not completely maintaining GFD and compared to people with T1D only they showed higher hyperglycemia rates (% time above range: 38.72 ± 20.94 vs 34.34 ± 20.94; P = 0.039). CONCLUSIONS: Individuals with T1D and CD who maintain GFD presented similar glucose metrics compared to youths with T1D only. Individuals not strictly maintaining GFD presented higher hyperglycemia rates.

Breastfeeding and presence of the companion of woman's choice during COVID-19 pandemic in Italy: regional population-based routine data and best practices at birth

OBJECTIVES: to describe the monthly trend of breastfeeding during hospitalization and the presence of companion of woman's choice during labour and birth, and the key regional responders' perspective of homogeneity/heterogeneity of the presence of the support person, before, during (February-May 2020), and after the first COVID-19 pandemic wave in a few Italian Regions. DESIGN: two-phase study. SETTING AND PARTICIPANTS: data from the italian birth certificate of six Italian Regions between 01.01.2019 and 31.03.2021 were analysed. Semi-structured interviews were conducted with the key regional respondents. MAIN OUTCOME MEASURES: the frequency distributions of breastfeeding and the presence of companion of woman's choice were calculated as a whole and for each Region. RESULTS: the infant feeding practices experienced smaller changes during COVID-19 pandemic than the presence of the companion of woman's choice during labour and birth, from January 2019 to March 2021. The highest value of exclusive breastfeeding was recorded in September 2020 (72.1%; 95%CI 71.3-72.8) in all Regions, while the lowest was recorded in March 2021 (62.5%; 95%CI 61.5-63.4). The presence of companion of woman's choice during labour and birth decreased during the pandemic and did not return to pre-pandemic levels. The highest value of presence of father during birth was recorded in March 2019 (59.0%; 95%CI 58.2-59.8), while the lowest in April 2020 (50.0%; 95%CI 49.1-50.8). The main emerging themes were: the existence of national, regional and local indications; the facilitators (e.g., Baby-Friendly Hospital Initiative implementation, strong motivation of the staff) and the critical points (e.g., inadequate analysis of the clinical-epidemiological context, inhomogeneous indications) of management of the support person presence. CONCLUSIONS: the emergency has changed the provision of health services that not always guaranteed the application of best practices. It would be desirable to work for assessing the appropriateness of the birth certificate data to collect more accurate information and to provide clinical recommendations.

Satisfaction with continuous glucose monitoring is positively correlated with time in range in children with type 1 diabetes.

AIMS: Continuous glucose monitoring (CGM) can improve glucometrics in children with type 1 diabetes (T1D), and its efficacy is positively related to glucose sensor use for at least 60% of the time. We therefore investigated the relationship between CGM satisfaction as assessed by a robust questionnaire and glucose control in pediatric T1D patients. METHODS: This was a cross-sectional study of children and adolescents with T1D using CGM. The CGM Satisfaction (CGM-SAT) questionnaire was administered to patients and demographic, clinical, and glucometrics data were recorded. RESULTS: Two hundred and ten consecutively enrolled patients attending 14 Italian pediatric diabetes clinics completed the CGM-SAT questionnaire. CGM-SAT scores were not associated with age, gender, annual HbA1c, % of time with an active sensor, time above range (TAR), time below range (TBR), and coefficient of variation (CV). However, CGM satisfaction was positively correlated with time in range (TIR, p < 0.05) and negatively correlated with glycemia risk index (GRI, p < 0.05). CONCLUSIONS: CGM seems to have a positive effect on glucose control in patients with T1D. CGM satisfaction is therefore an important patient-reported outcome to assess and it is associated with increased TIR and reduced GRI.

A novel smartphone App to support the clinical practice of pediatric ophthalmology and strabismus: the validation of visual acuity tests.

This study is aimed at describing the TreC Oculistica novel smartphone App that facilitated the clinical practice of pediatric ophthalmology and strabismus during the COVID-19 pandemic and at reporting on the validation of visual acuity tests in a home setting. The Trec Oculistica smartphone App was prescribed to eligible patients at the Pediatric Ophthalmology and Strabismus Clinic, Ophthalmology Unit of Rovereto Hospital, between September 2020 and March 2022. Four key indicators were identified for monitoring visual and visuo-motor functions remotely: visual acuity, ocular motility, head posture, and color vision. Clinicians selected few mobile applications (iOS, Android) and printable materials within the Trec Oculistica App: the Snellen Chart Visual Acuity App, the 9Gaze App, the eyeTilt App, the Color Blind test App, the LEA Symbols pdf, and the Snellen Chart pdf. All patients, aged 4 and older, were screened at home for visual acuity at 3 m and later in the clinic (LEA Symbols cabinet or Snellen computerized optotype). The 9Gaze, the eyeTilt, and the Color Blind test Apps were only recommended to a subset of patients based on clinical suspicion or diagnosis. The Wilcoxon signed rank sum test and weighted Cohen's kappa coefficient were applied to compare pairs of scores from different settings. The Trec Oculistica App was downloaded and activated by 97 patients or their caregiver. 40 patients were tested at home using the 9Gaze App, 7 used the eyeTilt App, and 11 used the Color-Blind test App. Families reported that all the Apps were easy and intuitive to use; clinicians reported that measurements were reliable. 82 eyes of 41 patients (mean age 5.2 years, SD ± 0.4, range 4.4-6.1) were tested for visual acuity using the self-administered LEA Symbols pdf. 92 eyes of 46 patients (mean age 11.6 years, SD ± 5.2, range 6-35) were evaluated using the self-administered Snellen Chart Visual Acuity App or the Snellen Chart pdf. Home median visual acuity score was statistically different from that registered in clinical setting for both the LEA Symbols pdf (P-value = 0.0074) and the Snellen Chart App and pdf (P-value = 0.0001). The strength of agreement was 0.12 (slight) for the LEA Symbols pdf, 0.50 (moderate) for the Snellen Chart Visual Acuity App, and 0.69 (substantial) for the Snellen Chart pdf. CONCLUSION: The novel TreC Oculistica smartphone App was a useful tool for facilitating the clinical practice of pediatric ophthalmology and strabismus during the COVID-19 pandemic. In the follow-up of strabismus patients and patients with suspected inherited retinal diseases, the 9Gaze, eyeTilt, and Color Blind test applications were deemed to be intuitive and easy to use by families and were considered reliable by clinicians. In a home setting, visual acuity tested by means of Snellen Charts was moderately congruent with the in-office examination. On the contrary, agreement was poor in younger children tested with the LEA Symbols pdf. WHAT IS KNOWN: • Teleophthalmology enables clinicians to evaluate patients' ocular diseases remotely and various tools are helpful for screening, follow-ups and treatment. • Smartphones can currently be used to obtain ocular images and vision measurements of patients' eyes and this information can be shared with the ophthalmologist for further evaluations and medical management (mhealth). WHAT IS NEW: • Smartphone Apps can be successfully used in a hybrid teleophthalmology service concerning first visits and follow-ups. • Apps and printable materials are easy, intuitive to use for patients and  also reliable for  clinicians.

Italian translation and validation of the CGM satisfaction scale questionnaire.

AIMS: Patient-reported outcomes (PROs) are increasingly important for assessing patient satisfaction with diabetes technologies. PROs must be assessed with validated questionnaires in clinical practice and research studies. Our aim was to translate and validate the Italian version of the continuous glucose monitoring (CGM) Satisfaction (CGM-SAT) scale questionnaire. METHODS: Questionnaire validation followed MAPI Research Trust guidelines and included forward translation, reconciliation, backward translation, and cognitive debriefing. RESULTS: The final version of the questionnaire was administered to 210 patients with type 1 diabetes (T1D) and 232 parents. The completion rate was excellent, with almost 100% of items answered. The overall Cronbach's coefficient was 0.71 and 0.85 for young people (patients) and parents indicating moderate and good internal consistency, respectively. Parent-young people agreement was 0.404 (95% confidence interval: 0.391-0.417), indicating moderate agreement between the two assessments. Factor analysis identified that factors assessing the "benefits" and "hassles" of CGM accounted for 33.9% and 12.9% of score variance in young people and 29.6% and 19.8% in parents, respectively. DISCUSSION: We present the successful Italian translation and validation of the CGM-SAT scale questionnaire, which will be useful for assessing satisfaction with Italian T1D patients using CGM systems.

The role of cardiac imaging before and after left atrial appendage standalone thoracoscopic exclusion.

AIMS: To assess the characteristics of left atrial appendage (LAA) stump and left atrial (LA) volume after standalone totally thoracoscopic LAA exclusion in 40 patients with nonvalvular atrial fibrillation (NVAF) and contraindications to oral anticoagulation (OAC), using cardiac computed tomography (CCT) and transoesophageal echocardiography (TOE). METHODS: Using CCT and TOE, we evaluated correct AtriClip Pro II positioning, the presence and characteristics of the LAA stump and the postprocedural LA volume, at 3 months' follow-up. Stump depth was measured with both CCT and TOE using a new method, based on left circumflex artery (LCX) course. RESULTS: After placement of AtriClip, all 40 patients discontinued OAC, and no stroke occurred. LAA exclusion was achieved in 40/40 patients at 3 months' follow-up. LAA stump (depth <10 mm in 12/18 stump, 67%) was observed in 18 patients. The overall (LA + LAA) volume and isolated LA volume were statistically different when comparing cases with and without LAA stump (P < 0.02). LAA ostium dimensions (perimeter and area) and LAA volume correlate with stump depth (P < 0.02). There was a high correlation between CCT and TOE in stump identification and depth measurement (P < 0.02). Compared with the baseline, CCT LA volume increased (P < 0.01) at 3 months' follow-up. CONCLUSION: Preprocedural and postprocedural CCT and TOE are useful and comparable in patients undergoing standalone totally thoracoscopic exclusion of LAA, because these imaging methods can identify anatomical LAA and LA characteristics predisposing for a postprocedural residual stump.

Early childhood eye diseases and perinatal risk factors: potential of record linkage between current information flows.

BACKGROUND: The aim of this study was to analyze the occurrence of specific maternal, obstetric or neonatal factors, by performing a comparison between children with refractive error, strabismus and/or amblyopia (cases) and unaffected children (controls) in the province of Trento (North-East Italy). METHODS: In 2012-2014, 14,346 children attending the second year of nursery school were assessed through the preschool orthoptic screening scheme (covering 91% of the preschool population). Record linkage was performed between the orthoptic screening database and birth records (birth confirmation certificate database) for the corresponding birth cohorts (2008-2010), to examine specific maternal factors (age, smoking, nationality/race), obstetric factors (type of delivery) and neonatal factors (gestational age, weight at birth, Apgar Score, congenital birth defects, hospitalization at birth). The correlations were investigated using univariate and multivariate analysis in accordance with the logistic regression method. RESULTS: During orthoptic screening, 6.4% of children were found to have at least one refractive error, with astigmatism being the most common condition (5.1%). 1.9% of children were found to have strabismus and 1.8% amblyopia. Multivariate logistic regression analysis showed that the risk of developing a refractive error is associated with: maternal age ≥45 years, foreign nationality, vacuum-assisted delivery and neonatal weight <1500 grams. An excessive risk of strabismus was observed in children whose mother had smoked during pregnancy (adjusted OR=1.64). CONCLUSIONS: Preschool orthoptic screening is a well-consolidated practice in the province of Trento, with adhesion values consistently over 90%. Studies of this type show the potential of record linkage between current information flows.

The COVID-19 vaccination in 4,772 pregnant women in the province of Trento (North-East Italy). Characteristics of vaccinated women.

OBJECTIVES: to investigate vaccine uptake among pregnant women during the 2nd and 3rd trimester of pregnancy. To describe the factors influencing vaccine uptake during pregnancy, comparing sociodemographic and clinical characteristics of pregnant women who were vaccinated during the 2nd or 3rd trimester with those who were not vaccinated, despite having the indication for vaccination. DESIGN: observational study with a cross-sectional approach and prevalence estimation in the population of women who gave birth in the study period, through record linkages between the ministry information flow Birth assistance certificate, the Regional vaccination register and the Italian flow for SARS-CoV-2 infections. SETTING AND PARTICIPANTS: the study included all the 4,772 pregnant women living in Trentino (north-east Italy), who were in the 2nd or 3rd trimester of pregnancy between the 5th May 2021 and the 28th February 2022 and who delivered in Trentino. MAIN OUTCOME MEASURES: vaccine uptake among pregnant women during the 2nd and 3rd trimester of pregnancy. Results: 33.3% of pregnant women got vaccinated with at least one dose of vaccine during the 2nd or 3rd trimester of pregnancy. Independent factors associated with vaccine uptake in the 2nd or 3rd trimester were the mother's citizenship, educational level, occupational status and age. CONCLUSIONS: the proportion of women who received at least one dose of COVID-19 vaccine during pregnancy was low. The results are important to start efficient actions to promote vaccination in pregnant women, particularly in the most vulnerable ones (unemployed, foreigners and with a low educational level), who appear to be less vaccinated frequently.

Anastomotic Leakage after Colorectal Surgery in Ovarian Cancer: Drainage, Stoma Utility and Risk Factors.

Objective: to evaluate the incidence of anastomotic leakage (AL), risk factors and utility of drainage and stoma in patients undergoing intestinal surgery for ovarian cancer in a single institution and in a review of the literature. Methods: retrospective study that includes consecutive patients undergoing debulking surgery with en bloc pelvic resection with rectosigmoid colectomy for ovarian cancer between 1 November 2011 and 31 December 2021. Data regarding patient and tumour characteristics, surgical procedure, hospitalisation, complications and follow-up were recorded and analysed. The PubMed database was explored for recent publications on this topic. Results: Seventy-five patients were enrolled in the study. All anastomoses were performed at a distance of >6 cm from the anal margin, with negative leak tests and tension-free anastomosis. Diverting stoma were performed in just three patients (4%). At least one perianastomotic pelvic drain was positioned in 71 patients (94.7%) and was removed on average on postoperative day 7. Four patients (5.3%) experienced AL. In all cases, the drain content was not the only sign of complication, as the clinical signs were also highly suggestive. Just one patient received conservative treatment. Average postoperative hospitalisation was 14.6 days (SD: ±9.7). There were no deaths at 30 and 60 days after surgery. Between the AL and non-AL groups, statistically significant differences were observed for age, Charlson Comorbidity Index, length of the intestinal resection and fitness for chemotherapy at 30 days. In ovarian cancer, rectosigmoid resection is a standardised procedure with comparable results for AL, and risk factors for AL are discretely homogeneous. What is neither homogeneous nor standardised according to the literature is the use of stomas and/or drains. Conclusion: use in the future of protective stoma and/or intra-abdominal drains is to be explored in selected and standardised situations to verify their preventive role.

Pregnancy outcomes in Italy during COVID-19 pandemic: a population-based cohort study.

OBJECTIVE: To compare the estimates of preterm birth (PTB; 22-36 weeks gestational age, GA) and stillbirth rates during COVID-19 pandemic in Italy with those recorded in the three previous years. DESIGN: A population-based cohort study of liveborn and stillborn infants was conducted using data from Regional Health Systems and comparing the pandemic period (March 1st , 2020-March 31st , 2021, N= 362,129) to an historical period (January 2017- February 2020, N=1,117,172). The cohort covered 84.3% of the births in Italy. METHODS: Poisson regressions were run in each Region and meta-analyses were performed centrally. We used an interrupted time series regression analysis to study the trend of preterm births from 2017 to 2021. MAIN OUTCOME MEASURES: The primary outcomes were PTB and stillbirths. Secondary outcomes were late PTB (32-36 weeks' GA), very PTB (<32 weeks' GA), and extremely PTB (<28 weeks' GA), overall and stratified into singleton and multiples. RESULTS: The pandemic period compared with the historical one was associated with a reduced risk for PTB (Risk Ratio: 0.91; 95% Confidence Interval, CI: 0.88, 0.93), late PTB (0.91; 0.88, 0.94), very PTB (0.88; 0.84, 0.91), and extremely PTB (0.88; 0.82, 0.95). In multiples, point estimates were not very different, but had wider CIs. No association was found for stillbirths (1.01; 0.90, 1.13). A linear decreasing trend in PTB rate was present in the historical period, with a further reduction after the lockdown. CONCLUSIONS: We demonstrated a decrease in PTB rate after the introduction of COVID-19 restriction measures, without an increase in stillbirths.

Hepatitis C virus burden: Treating and educating people without prejudice.

BACKGROUND: Hepatitis C virus (HCV) infection has a worldwide incidence of 1.1%. In Italy, 60% of people who inject drugs (PWIDs) and are receiving assistance for substance use disorder are infected with HCV. However, this subset of patients has extremely limited access to care due to multiple factors, including alcohol abuse, psychological comorbidities, and homeless status. AIM: To describe the impact of our HCV-dedicated service for substance use disorder (SSUD) service on PWIDs receiving anti-HCV therapy. METHODS: A dedicated, multidisciplinary team was set up at the SSUD of Trento in October 2020 to provide antiviral treatment to HCV RiboNucleic Acid-positive patients with an active or previous history of substance abuse. The treatment was followed by a health education program. Patients were treated with Direct-Acting Antivirals (DAAs). Data were retrospectively analyzed to assess the efficacy of our dedicated program in terms of therapy completion, HCV eradication, and compliance (primary endpoint). The rate of HCV reinfection and DAA-related toxicity were also assessed (secondary endpoints). RESULTS: A total of 40 patients were enrolled in the study: 28 (70.0%) were treated with Sofosbuvir/Velpatasvir, while 12 (30.0%) received Glecaprevir/Pibrentasvir. At the time of inclusion in the study, 36 patients were receiving opioid agonist maintenance therapy, whilst another 4 had just finished the treatment. 37.5% had a history of alcoholism and 42.5% received concomitant psychiatric treatment. All 40 patients (100.0%) completed the therapy cycle and 92.5% of patients adhered to the program. All patients tested negative for viral load at the end of the treatment. There were no significant drug interactions with common psychiatric treatments and no side effects were observed. The sustained virological response was achieved in 92.5% of cases with good tolerability, although two patients discontinued treatment temporarily. After HCV eradication, one patient died from an overdose, another from complications of cirrhosis, and one reinfection occurred. CONCLUSION: Very high adherence to therapy and good tolerability was observed in our series of HCV patients treated at the SSUD, regardless of the substance abuse condition. Further validation in a larger population is required.

Impact of intermittently scanned continuous glucose monitoring with alarms on sleep and metabolic outcomes in children and adolescents with type 1 diabetes.

AIMS: Data about sleep quality and quantity are not available in patients with type 1 diabetes (T1D) using intermittently scanned continuous glucose monitoring (isCGM). We questioned whether the isCGM with alarms could fragment sleep in patients and parents, compared to isCGM without alarms. METHODS: A prospective, observational study including 47 child-adolescents with T1D who had experience with isCGM without alarms (Freestyle Libre 1-FSL1). They were asked to wear the isCGM with alarms (Freestyle Libre 2-FSL2) for 14 days. Patients enrolled and their caregiver (s), during a 14 day period with FSL1 and the following 14 days with FSL2, completed psychosocial and sleep-related questionnaires. Furthermore they wore an actigraph that was downloaded to a web platform and processed by the validated and certified algorithm "Dormi®." RESULTS: By the switch to the alarmed FSL2 we found about a 5% increase in Time In Range (from 62.5 to 67.8%), a reduction in time spent in hypoglycemia, number of weekly hypoglycemic events, and coefficient of variation. We did not find significant differences in sleep parameters in patients and their parents; therefore, alarms did not worsen the duration and quality of sleep. A significant improvement in the Quality of Life was perceived by parents using FSL2. CONCLUSIONS: Introduction of alarms in isCGM systems gives, in the short term, an improvement in metabolic control in terms of time in range and reduction in hypoglycemia, without worsening duration and quality of sleep, measured by actigraphy, in children-adolescent and their parents.

Acute Hematological Toxicity during Cranio-Spinal Proton Therapy in Pediatric Brain Embryonal Tumors.

BACKGROUND: Embryonal tumors represent a heterogeneous entity of brain tumors that need a multidisciplinary treatment including cranio-spinal irradiation (CSI), with a known impact on the acute toxicity. Proton therapy (PT) boasts a reduction in acute hematological toxicity. METHODS: We retrospectively examined 20 pediatric patients affected by high-risk medulloblastoma and other rare embryonal brain tumors subjected to CSI with PT from September 2016 to April 2020. Before CSI, all patients received induction chemotherapy, and three patients additionally received two high-dose courses with thiotepa, followed by an autologous haemopoietic stem cell transplantation. We recorded the total white blood cell count, absolute neutrophil count, platelets, and hemoglobin levels for all patients during PT. RESULTS: Leucocytes and neutrophils decreased directly after the beginning of treatment, reaching a complete recovery at the end of treatment. Hemoglobin values remained constant over the treatment course. The median platelet value decreased until reaching a plateau around halfway through therapy, followed by a slow increase. No cases of febrile neutropenia or severe infections were reported. No treatment discontinuation due to hematological toxicity was necessary. CONCLUSIONS: CSI with PT was proven to be safe in this setting of pediatric patients. Our study showed that despite all patients having undergone chemotherapy prior to irradiation, no serious hematological toxicity was reported at the end of the treatment with PT, and, therefore, no treatment was discontinued or delayed.

Risk factors for nodal involvement in early-stage rectal cancer: a new scoring system based on the analysis of 326 cases.

BACKGROUND: the purpose of this study was to identify which clinicopathological features of early-stage rectal cancer (ESRC) are significantly correlated with the risk of local-regional lymph node metastases (LNM) and to quantify the strength of this association through a novel scoring system. According to several case studies, about 20% of operated ESRC are found with occult lymph nodal metastases at the histological examination. The low frequency of local recurrence in these tumors treated with total mesorectal excision (TME) compared to transanal approaches highlights the role of mesorectal lymph nodes as a site of metastatic location. METHODS: Overall, 386 consecutive patients with ESRC treated with radical resection and TME were examined in a retrospective, observational multi-centric study, operated between 2007 and 2019 in seven centers. Demographic and tumor related clinicopathological characteristics were identified, collected and analyzed. Each variable was specifically weighted based on the strength of its association with the presence of nodal metastases. A scoring system using these weighted variables was developed. RESULTS: Six variables were found to be significantly associated with local regional LNM: lymphatic invasion combined with vascular invasion, poor differentiation (G3), stage T2, age ≥60 years, male sex, perineural invasion. A novel scoring system weighted on the presence of each of these variables able to quantify the risk of LNM in ESRC was developed. CONCLUSIONS: The proposed scoring system is a good predictor of the risk of LNM and should be of help in the decision-making process for ESRC cases diagnosed either by local excision or endoscopic biopsy.